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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0846

2. Registrant Information.

Registrant Reference Number: M-413745-01-2

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc

Address: Suite 200, 160 Quarry Park Blvd SE

City: Calgary

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

3. Select the appropriate subform(s) for the incident.

Scientific Study

4. Date registrant was first informed of the incident.

5. Location of incident.

6. Date incident was first observed.

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

PMRA Registration No. 27526      PMRA Submission No.       EPA Registration No.

Product Name: TRIFLOXYSTROBIN TECHNICAL FUNGICIDE

• Active Ingredient(s)
  • TRIFLOXYSTROBIN (CGA 279202)

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform VII: Scientific Study

1. Study Reference

Title In vitro Chromosome Aberration Test in Chinese Hamster V79 Cells

Date 08-SEP-11

2. a) Is an extension needed to translate the document?

No

3. Type of incident identified in the study

New health or environmental hazard

4. Describe the incident identified in the study (e.g. study demonstrates an increased risk to non-Hodgkin's Lymphoma after exposure to pesticide X)

CGA 321113 ((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid [CAS# 252913-85-2]), a plant, livestock, soil, and rat metabolite of trifloxystrobin, was concluded to be clastogenic in an in vitro chromosome aberration assay in V79 cells Chinese hamster at the two highest evaluated concentrations with and without metabolic activation. Cultures were exposed for 4 hours up to 150 g/ml in the absence of S9 mix and up to 600 g/ml in the presence of S9 mix. For both conditions, cells were harvested 18 hours after the beginning of treatment. Cytotoxicity was observed in the absence of S9 at 125 and 150 g/ml and in the presence of S9 from 375 g/ml and above. An increase in aberrations was observed at the two highest evaluated concentratons, 100 and 125 g/ml without S9 and 350 and 400 g/ml in the presence of S9. Only one valid trial was performed in this study.

5. a) Was the study discontinued before completion?

No

5. b) Provide the reason for discontinuation

6. If the study is ongoing, what is the expected completion date?

For Registrant use only

7. Provide supplemental information here

No evidence of genotoxicity was observed in in vitro mutagenicity assays (Ames and HPRT) or in in vivo assays (unscheduled DNA synthesis and mouse micronucleus) on this metabolite. Thus, the overall weight of the evidence indicates that this metabolite is not genotoxic. The reports for the complete set of genotoxicity studies are available upon request.